FDA DrugClass IINotable

FDA Recall: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL O

Date: 2026-07-29
Brand: Rohto-Mentholatum (Vietnam) Co., Ltd.
Category: Drug
FDA Class: Class II

Description

Lack of Assurance of Sterility

Hazard

Lack of Assurance of Sterility

Remedy

65219 cartons

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